Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04297943 |
| Other study ID # |
115441 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2020 |
| Est. completion date |
May 31, 2022 |
Study information
| Verified date |
February 2020 |
| Source |
Western University, Canada |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study will investigate the effectiveness of 3D printed splints for the treatment of
thumb osteoarthritis (CMC OA). Currently, these splints are made by Occupational Therapists
and Physical Therapists out of low temperature plastic, and formed on the patient's hand. 3D
printed splints involve taking a photographic scan of the hand and creating a digital file of
the splint. This is then printed and fit on the patient. This study will compare the
effectiveness of these methods of splint fabrication. Our outcomes will include measurements
of pain relief, adherence, patient satisfaction, muscle contraction and CT imaging during
pinch tasks to measure the ability of these splint types to support the CMC joint.
Description:
This study will be prospective, randomized, controlled trial. Patients will be identified for
potential inclusion by the surgeons at HULC. The standard of clinical care is for diagnosis
of CMC is to perform X-rays of the hand and this is done routinely. Based on these images and
clinical evaluation, surgeons will establish a diagnosis of CMC, and provide a grading of
severity based on the Eaton/Littler Classification on a referral pad. Eligible participants
will then be asked to attend the Clinical Research Laboratory within HULC, where one of the
co-investigators listed will present the letter of information and obtain informed consent.
Patients who agree to participate will be asked to complete 3 functional outcomes
questionnaires (i.e. DASH, PRWHE, and VAS pain scale). Bilateral wrist and thumb range of
motion, lateral and tripod pinch strength, and grip strength will also be assessed.
Following the initial assessment, patients will be randomized into one of two groups.
Patients will be stratified based on their initial referral by the hand surgeon according to
CMC OA severity results to ensure that equal numbers of participants fall into each treatment
arm based on the Eaton Classification of their CMC OA. After randomization, patients will
attend splinting visit #1 (based on scheduling availability) either the Hand Therapy
Department at St. Joseph's Health Care London or Hand Therapy Canada, a private clinic in
London. Regardless of group allocation or location of therapy visit, patients will not be
charged for their therapy visits or for their splint.
Splinting Visit #1
Group one will be fit with a low temperature custom thermoplastic brace at one of the
aforementioned clinic locations and then booked for a follow up appointment in the clinical
research laboratory at SJHC two weeks later.
Group two will have their hand placed in a scanner that takes multiple photographs of the
hand and reconstructs these photos into a single 3 dimensional computer image. From there,
one of the co-investigators (MS) will "draw" the splint, and send to a 3D printer. Patients
will come back to a clinic location for fitting, and will then follow up 2 weeks after splint
fitting at the clinical research laboratory 2 weeks later.
Regardless of group allocation, each splint will have a temperature sensor placed into the
splint. This sensor is similar to a watch battery and collects and records several thousand
temperature readings on pre-set intervals. Participants will be told that the the sensor
records data on position of the hand in space, but in fact, recording the temperature will
provide information about adherence with the splinting program.
CT Scan
Patients undergo a 4D CT scan of bilateral thumb CMC joints. This will include scans at rest,
while performing lateral pinch of 2kg, 5kg, and maximum pinch (if greater than 5kg). They
will then apply their splint, and these images will be repeated while wearing the splint.
Follow Up Visits
Participants will be asked to wear their splint during most functional activities for 8
weeks, with the goal of wearing their splint for at least half of their waking hours. They
will be asked to keep a daily logbook of the amount of time spent in the splint and will keep
these records until the 2-month visit. All participants will return to therapy once every 2
weeks. The purpose of these follow up visits will be to download the data from the
temperature sensors and to ensure there is no skin irritation or evidence of any skin
breakdown from splint use.
2-month visit
At 2 months, participants will be asked to repeat the three functional outcomes
questionnaires and will have their ROM and strength re-tested as in visit #1. They will also
have a surface EMG recording of their muscle contractions while in the splint. At this point,
the sensors will be removed from the splints for final analysis. Patients will also turn in
their logbooks of splint usage, and complete a splinting satisfaction questionnaire. They
will then attend a second visit to the CT scanner for a repeat imaging session exactly as
listed above.
Final Visit
Participants will be call back to the clinic for a final evaluation at 12 months. At this
point, all measures will be repeated with the exception of the CT scans.
